Erectile Dysfunction Following Radiation TherapyNCT03986359
Treatment of Erectile Dysfunction With Low-intensity Extracorporeal Shockwave Therapy
A study testing low energy extracorporeal shockwave therapy in people with Erectile Dysfunction Following Radiation Therapy, run by National Taiwan University at 1 site in Taiwan.
Trial summary
This study is a prospective, randomized, single-blinded, cross-over trial to investigate the efficacy of low-intensity extracorporeal shockwave therapy in the treatment of erectile dysfunction (ED). We will enroll 60 subjects (International Index of Erectile Function Questionnaires, 5 ≦ IIEF-5 ≦ 21). Read more about this study
- Who is it for?
- Ages 20 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction Following Radiation Therapy
- What is being tested?
- low energy extracorporeal shockwave therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2019to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 20 ~ 70 year-old man, suffering from ED for over 6 months.
- 5 ≦ IIEF-5 ≦ 21.
Who cannot join
- Patients with penile implant, prior radical prostatectomy, rectal surgery, radiation therapy to the pelvic area, spinal cord injury, prostate cancer, bladder cancer, interstitial cystitis, or major depression.
- Patient ever received low intensity shockwave or who does not have sex intercourse in recent six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Erectile Dysfunction With Low-intensity Extracorporeal Shockwave Therapy: A Prospective, Randomized, Single-blind, Cross-over Study
This study is a prospective, randomized, single-blinded, cross-over trial to investigate the efficacy of low-intensity extracorporeal shockwave therapy in the treatment of erectile dysfunction (ED). We will enroll 60 subjects (International Index of Erectile Function Questionnaires, 5 ≦ IIEF-5 ≦ 21). 30 subjects receive ESWT (LM-IASO, Litemed Co., Taiwan) for 6 courses in 3 weeks (0.05mJ/mm2, 3000 pulses) and 30 subjects receive Sham therapy for 3 weeks (the machine turning on but the energy is zero). After 3 weeks, the two groups are cross over. The primary outcome is the 4th week change from baseline for IIEF-5 score. Secondary outcomes are the 8th week change from baseline for IIEF-5 score, EHS, QoL; AEs. The between-group relationships of baseline and 4-week data were evaluated by using the Student's t-test or Mann-Whitney U-test where appropriate. Multiple linear regression was carried out to test the variables associated with treatment outcome. P-values < 0.05 were considered statistically significant.
Read the detailed description
Low-intensity extracorporeal shockwave therapy (LI-ESWT) was proved to be useful in various medical conditions; for example, neovascularization in myocardial ischemia, nonhealing wounds, ED and chronic pelvic pain syndrome.
The use of LI-ESWT has been increasingly proposed as a treatment for ED over the last decade. Overall, most of these studies reported encouraging results, regardless of variation in LI-ESWT set-up parameters or treatment protocols. As a whole these studies suggest that LI-ESWT could significantly improve the IIEF-5 and Erection Hardness Score of mild ED patients. However, no randomized control trial with cross-over designed studies so far.
This is a prospective, randomized, single-blind, cross-over clinical study. This study will be performed in outpatient setting of NTUH. Written informed consent will be given by all participants before entering the study. The subjects are treated at the therapy room of the department of urology, NTUH. All subjects would not pay any cost for this treatment/study. This study was approved by the institutional review board at National Taiwan University Hospital (NTUH, No. T-NTUH-57401).
Inclusion criteria: were patient age 20 ~ 70 year-old man, suffering from ED for over 6 months, and 5 ≦ IIEF-5 ≦ 21. The written informed consent forms from all subjects who met the inclusion criteria were obtained.
Exclusion criteria: Patients with penile implant, prior radical prostatectomy, rectal surgery, radiation therapy to the pelvic area, spinal cord injury, prostate cancer, bladder cancer, interstitial cystitis, or major depression were excluded. Patient ever received low intensity shockwave or who does not have sex intercourse in recent six months will be excluded.
Measurement of outcomes
Primary outcome: the 4th week and the 8th week change from baseline for IIEF-5 score change from baseline for IIEF-5 score.
Secondary outcomes: Penile Doppler Ultrasound (PDU) at 4th and 8th week , EHS, QoL; AEs
Methodology All patients diagnosed of erectile dysfunction will receive blood sampling of serum testosterone and lipid profile at the beginning of the study. All patients were treated at out-patient clinic. 30 subjects receive LI-ESWT (LM-IASO, Litemed Co., Taiwan) for 6 courses in 3 weeks (0.05mJ/mm2, 3000 pulses) and 30 subjects receive Sham therapy for 3 weeks (the machine turning on but the energy is zero). LI-ESWT is delivered by a probe that was attached to a electrohydraulic unit with a wide-focused shockwave source. The penis is manually stretched, and shockwaves are delivered to the whole penis shaft and penis base. The duration of each ESWT session is about 30 minutes, and comprised 3000 pulses (0.05mJ/mm2), and a frequency of 100/min.
Safety Considerations The peri- and post-treatment adverse events (AEs), including local pain, edema or hematoma were recorded and compared. With consideration of safety issue, any moderate/severe local pain or hematoma would be immediately reported and well inspected.
Follow-up The following parameters are assessed before treatment and weekly during the treatment: IIEF-5 score, EHS, QoL; AEs.
- Being tested
- low energy extracorporeal shockwave therapy
- Keywords
- low-intensity extracorporeal shockwave therapy, Erectile Dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low energy extracorporeal shockwave therapyDevice
Low-intensity extracorporeal shockwave therapy (LI-ESWT) was proved to be useful in various medical conditions; for example, neovascularization in myocardial ischemia, nonhealing wounds, ED and chronic pelvic pain syndrome
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 30 subjects receive ESWT (LM-IASO, Litemed Co., Taiwan) for 6 courses in 3 weeks (0.05mJ/mm2, 3000 pulses). Thereafter, the two groups are cross over. Receives: Device: low energy extracorporeal shockwave therapy |
| 2 | Sham comparator | 30 subjects receive Sham therapy for 3 weeks (the machine turning on but the energy is zero). Thereafter, the two groups are cross over. Receives: Device: low energy extracorporeal shockwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF-5 score
the 4th week and the 8th week change from baseline for IIEF-5 score change from baseline for IIEF-5 score.
The IIEF-5 Questionnaire
Over the past 6 months:
- How do you rate your confidence that you could get and keep an erection? (1-5)
- When you had erections with sexual stimulation, how often were your erections hard enough for penetration? (1-5)
- During sexual intercourse, how often were you able to maintain your erection after you had penetrated your partner? (1-5)
- During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse? (1-5)
- When you attempted sexual intercourse, how often was it satisfactory for you? (1-5) Total Score: 1-7: Severe ED 8-11: Moderate ED 12-16: Mild-moderate ED 17-21: Mild ED 22-25: No ED
Measured: the 4th week and the 8th week
Secondary outcomes (3)
Penile Doppler Ultrasound (PDU)
PDU at 4th and 8th week
Measured: the 4th week and the 8th week
EHS（Erection Hardness Score）
EHS at 4th and 8th week EHS score
How would you rate the hardness of your erection? select one of the following options:
- 0 - Penis does not enlarge.
- 1 - Penis is larger, but not hard.
- 2 - Penis is hard, but not hard enough for penetration.
- 3 - Penis is hard enough for penetration, but not completely hard.
- 4 - Penis is completely hard and fully rigid.
Measured: the 4th week and the 8th week
QoL: questionnaire
Quality-of-life questionnaire at 4th and 8th week
Score 0 (the best) - 6 (the worst)
Measured: the 4th week and the 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start1 Sep 2019 (estimated)
- Primary completion28 Feb 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Erectile Dysfunction Following Radiation TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- We prospectively assessed the clinical outcome of LI-ESWT for the treatment of ED of organic origin. This study was approved by the institutional review board at National Taiwan University Hospital (NTUH, No. T-NTUH-57401).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fu-Shun Hsu, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986359
- Sponsor's protocol ID
- T-NTUH-57401
- Status last verified
- Aug 2019
- First submitted
- 11 Jun 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sokolakis I, Hatzichristodoulou G. Clinical studies on low intensity extracorporeal shockwave therapy for erectile dysfunction: a systematic review and meta-analysis of randomised controlled trials. Int J Impot Res. 2019 May;31(3):177-194. doi: 10.1038/s41443-019-0117-z. Epub 2019 Jan 21.
PubMed 30664671Campbell JD, Trock BJ, Oppenheim AR, Anusionwu I, Gor RA, Burnett AL. Meta-analysis of randomized controlled trials that assess the efficacy of low-intensity shockwave therapy for the treatment of erectile dysfunction. Ther Adv Urol. 2019 Mar 29;11:1756287219838364. doi: 10.1177/1756287219838364. eCollection 2019 Jan-Dec.
PubMed 30956690Dong L, Chang D, Zhang X, Li J, Yang F, Tan K, Yang Y, Yong S, Yu X. Effect of Low-Intensity Extracorporeal Shock Wave on the Treatment of Erectile Dysfunction: A Systematic Review and Meta-Analysis. Am J Mens Health. 2019 Mar-Apr;13(2):1557988319846749. doi: 10.1177/1557988319846749.
PubMed 31027441
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Erectile Dysfunction With Low-intensity Extracorporeal Shockwave Therapy: A Prospective, Randomized, Single-blind, Cross-over Study
- ClinicalTrials.gov ID
- NCT03986359
- Acronym / sponsor ID
- T-NTUH-57401
- Keywords
- low-intensity extracorporeal shockwave therapy, Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 14 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, randomized, single-blinded, cross-over trial to investigate the efficacy of low-intensity extracorporeal shockwave therapy in the treatment of erectile dysfunction (ED). We will enroll 60 subjects (International Index of Erectile Function Questionnaires, 5 ≦ IIEF-5 ≦ 21). 30 subjects receive ESWT (LM-IASO, Litemed Co., Taiwan) for 6 courses in 3 weeks (0.05mJ/mm2, 3000 pulses) and 30 subjects receive Sham therapy for 3 weeks (the machine turning on but the energy is zero). After 3 weeks, the two groups are cross over. The primary outcome is the 4th week change from baseline for IIEF-5 score. Secondary outcomes are the 8th week change from baseline for IIEF-5 score, EHS, QoL; AEs. The between-group relationships of baseline and 4-week data were evaluated by using the Student's t-test or Mann-Whitney U-test where appropriate. Multiple linear regression was carried out to test the variables associated with treatment outcome. P-values < 0.05 were considered statistically significant.
Detailed description
Low-intensity extracorporeal shockwave therapy (LI-ESWT) was proved to be useful in various medical conditions; for example, neovascularization in myocardial ischemia, nonhealing wounds, ED and chronic pelvic pain syndrome.
The use of LI-ESWT has been increasingly proposed as a treatment for ED over the last decade. Overall, most of these studies reported encouraging results, regardless of variation in LI-ESWT set-up parameters or treatment protocols. As a whole these studies suggest that LI-ESWT could significantly improve the IIEF-5 and Erection Hardness Score of mild ED patients. However, no randomized control trial with cross-over designed studies so far.
This is a prospective, randomized, single-blind, cross-over clinical study. This study will be performed in outpatient setting of NTUH. Written informed consent will be given by all participants before entering the study. The subjects are treated at the therapy room of the department of urology, NTUH. All subjects would not pay any cost for this treatment/study. This study was approved by the institutional review board at National Taiwan University Hospital (NTUH, No. T-NTUH-57401).
Inclusion criteria: were patient age 20 ~ 70 year-old man, suffering from ED for over 6 months, and 5 ≦ IIEF-5 ≦ 21. The written informed consent forms from all subjects who met the inclusion criteria were obtained.
Exclusion criteria: Patients with penile implant, prior radical prostatectomy, rectal surgery, radiation therapy to the pelvic area, spinal cord injury, prostate cancer, bladder cancer, interstitial cystitis, or major depression were excluded. Patient ever received low intensity shockwave or who does not have sex intercourse in recent six months will be excluded.
Measurement of outcomes
Primary outcome: the 4th week and the 8th week change from baseline for IIEF-5 score change from baseline for IIEF-5 score.
Secondary outcomes: Penile Doppler Ultrasound (PDU) at 4th and 8th week , EHS, QoL; AEs
Methodology All patients diagnosed of erectile dysfunction will receive blood sampling of serum testosterone and lipid profile at the beginning of the study. All patients were treated at out-patient clinic. 30 subjects receive LI-ESWT (LM-IASO, Litemed Co., Taiwan) for 6 courses in 3 weeks (0.05mJ/mm2, 3000 pulses) and 30 subjects receive Sham therapy for 3 weeks (the machine turning on but the energy is zero). LI-ESWT is delivered by a probe that was attached to a electrohydraulic unit with a wide-focused shockwave source. The penis is manually stretched, and shockwaves are delivered to the whole penis shaft and penis base. The duration of each ESWT session is about 30 minutes, and comprised 3000 pulses (0.05mJ/mm2), and a frequency of 100/min.
Safety Considerations The peri- and post-treatment adverse events (AEs), including local pain, edema or hematoma were recorded and compared. With consideration of safety issue, any moderate/severe local pain or hematoma would be immediately reported and well inspected.
Follow-up The following parameters are assessed before treatment and weekly during the treatment: IIEF-5 score, EHS, QoL; AEs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- We prospectively assessed the clinical outcome of LI-ESWT for the treatment of ED of organic origin. This study was approved by the institutional review board at National Taiwan University Hospital (NTUH, No. T-NTUH-57401).
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: low energy extracorporeal shockwave therapy30 subjects receive ESWT (LM-IASO, Litemed Co., Taiwan) for 6 courses in 3 weeks (0.05mJ/mm2, 3000 pulses). Thereafter, the two groups are cross over. |
| 2 | Sham comparator | Device: low energy extracorporeal shockwave therapy30 subjects receive Sham therapy for 3 weeks (the machine turning on but the energy is zero). Thereafter, the two groups are cross over. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients age 20 ~ 70 year-old man, suffering from ED for over 6 months.
- 5 ≦ IIEF-5 ≦ 21.
Key exclusion criteria (2 listed)
- Patients with penile implant, prior radical prostatectomy, rectal surgery, radiation therapy to the pelvic area, spinal cord injury, prostate cancer, bladder cancer, interstitial cystitis, or major depression.
- Patient ever received low intensity shockwave or who does not have sex intercourse in recent six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low energy extracorporeal shockwave therapyLow-intensity extracorporeal shockwave therapy (LI-ESWT) was proved to be useful in various medical conditions; for example, neovascularization in myocardial ischemia, nonhealing wounds, ED and chronic pelvic pain syndrome | Device | 1, 2 |
Primary outcome
IIEF-5 score
Time frame: the 4th week and the 8th week
the 4th week and the 8th week change from baseline for IIEF-5 score change from baseline for IIEF-5 score. The IIEF-5 Questionnaire Over the past 6 months: 1. How do you rate your confidence that you could get and keep an erection? (1-5) 2. When you had erections with sexual stimulation, how often were your erections hard enough for penetration? (1-5) 3. During sexual intercourse, how often were you able to maintain your erection after you had penetrated your partner? (1-5) 4. During sexual intercourse, how difficult was it to maintain your erection to completion of intercourse? (1-5) 5. When you attempted sexual intercourse, how often was it satisfactory for you? (1-5) Total Score: 1-7: Severe ED 8-11: Moderate ED 12-16: Mild-moderate ED 17-21: Mild ED 22-25: No ED
3 secondary outcomes
Penile Doppler Ultrasound (PDU)
Time frame: the 4th week and the 8th week
EHS（Erection Hardness Score）
Time frame: the 4th week and the 8th week
QoL: questionnaire
Time frame: the 4th week and the 8th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Results publication: PubMed 30664671Sokolakis I, Hatzichristodoulou G. Clinical studies on low intensity extracorporeal shockwave therapy for erectile dysfunction: a systematic review and meta-analysis of randomised controlled trials. Int J Impot Res. 2019 May;31(3):177-194. doi: 10.1038/s41443-019-0117-z. Epub 2019 Jan 21.
- Results publication: PubMed 30956690Campbell JD, Trock BJ, Oppenheim AR, Anusionwu I, Gor RA, Burnett AL. Meta-analysis of randomized controlled trials that assess the efficacy of low-intensity shockwave therapy for the treatment of erectile dysfunction. Ther Adv Urol. 2019 Mar 29;11:1756287219838364. doi: 10.1177/1756287219838364. eCollection 2019 Jan-Dec.
- Results publication: PubMed 31027441Dong L, Chang D, Zhang X, Li J, Yang F, Tan K, Yang Y, Yong S, Yu X. Effect of Low-Intensity Extracorporeal Shock Wave on the Treatment of Erectile Dysfunction: A Systematic Review and Meta-Analysis. Am J Mens Health. 2019 Mar-Apr;13(2):1557988319846749. doi: 10.1177/1557988319846749.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low energy extracorporeal shockwave therapy in people with Erectile Dysfunction Following Radiation Therapy, run by National Taiwan University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IIEF-5 score (time frame: the 4th week and the 8th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03986359, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.